DK2305263T3 - Stabilized amorphous forms of imatinib mesylate - Google Patents

Stabilized amorphous forms of imatinib mesylate

Info

Publication number
DK2305263T3
DK2305263T3 DK10178116.9T DK10178116T DK2305263T3 DK 2305263 T3 DK2305263 T3 DK 2305263T3 DK 10178116 T DK10178116 T DK 10178116T DK 2305263 T3 DK2305263 T3 DK 2305263T3
Authority
DK
Denmark
Prior art keywords
imatinib mesylate
amorphous forms
stabilized amorphous
stabilized
imatinib
Prior art date
Application number
DK10178116.9T
Other languages
Danish (da)
Inventor
Elisabete Goncalves
Oskar Kalb
Michael Mutz
Wolfgang Wirth
Original Assignee
Novartis Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=38229765&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2305263(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novartis Ag filed Critical Novartis Ag
Application granted granted Critical
Publication of DK2305263T3 publication Critical patent/DK2305263T3/en

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/04—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
DK10178116.9T 2007-06-07 2007-06-07 Stabilized amorphous forms of imatinib mesylate DK2305263T3 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP07109816A EP2000139A1 (en) 2007-06-07 2007-06-07 Stabilized amorphous forms of imatinib mesylate

Publications (1)

Publication Number Publication Date
DK2305263T3 true DK2305263T3 (en) 2012-10-22

Family

ID=38229765

Family Applications (1)

Application Number Title Priority Date Filing Date
DK10178116.9T DK2305263T3 (en) 2007-06-07 2007-06-07 Stabilized amorphous forms of imatinib mesylate

Country Status (27)

Country Link
US (4) US20100178336A1 (en)
EP (2) EP2305263B1 (en)
JP (2) JP5380440B2 (en)
KR (2) KR101454086B1 (en)
CN (2) CN101678023A (en)
AR (1) AR067328A1 (en)
AU (1) AU2008262059B2 (en)
BR (1) BRPI0812442A2 (en)
CA (1) CA2687741A1 (en)
CL (1) CL2008001658A1 (en)
CO (1) CO6241118A2 (en)
CY (1) CY1113178T1 (en)
DK (1) DK2305263T3 (en)
ES (1) ES2391625T3 (en)
HK (1) HK1150764A1 (en)
IL (2) IL202157A0 (en)
MX (1) MX2009013272A (en)
MY (1) MY148878A (en)
NZ (3) NZ598428A (en)
PL (1) PL2305263T3 (en)
PT (1) PT2305263E (en)
RU (1) RU2489149C2 (en)
SG (1) SG182175A1 (en)
SI (1) SI2305263T1 (en)
UY (1) UY31125A1 (en)
WO (1) WO2008154262A1 (en)
ZA (2) ZA200907961B (en)

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101041203B1 (en) * 2007-09-25 2011-06-13 테바 파마슈티컬 인더스트리즈 리미티드 Stable Imatinib Composition
CZ20098A3 (en) * 2009-01-13 2010-07-21 Zentiva, K.S. Medicinal forms of tyrosine kinase inhibitors
CZ2009570A3 (en) 2009-08-26 2011-03-09 Zentiva, K. S. Preparation, stabilization and use of imatinib mesylate polymorphs for development of medicinal forms
WO2012080703A1 (en) * 2010-12-15 2012-06-21 Cipla Limited Pharmaceutical composition comprising imatinib
WO2013077815A1 (en) 2011-11-24 2013-05-30 Ak Farma İlaç Sanayi Ve Ticaret A.Ş. Imatinib solid dosage forms reconstituted just before use
KR101386697B1 (en) 2012-06-18 2014-04-18 아주대학교산학협력단 Composition for preventing or treating vascular permeability disease comprising imatinib or pharmaceutically acceptable salts thereof as active ingredient
US9439903B2 (en) 2012-10-25 2016-09-13 Cadila Healthcare Limited Process for the preparation of amorphous imatinib mesylate
CN103784411B (en) * 2012-11-01 2016-03-23 齐鲁制药(海南)有限公司 A kind of erlotinid hydrochloride Pharmaceutical composition and preparation method thereof
WO2015110949A1 (en) 2014-01-22 2015-07-30 Novartis Ag Imatinib as cholesterol decreasing agent
EP3752132B1 (en) * 2018-02-13 2021-12-08 Sandoz AG Pharmaceutical composition of brigatinib
CN109044977A (en) * 2018-10-26 2018-12-21 武汉工程大学 A kind of pleasure is cut down for Buddhist nun's solid dispersions and preparation method thereof and preparation
WO2021083346A1 (en) * 2019-11-01 2021-05-06 正大天晴药业集团股份有限公司 Pharmaceutical composition comprising quinazoline derivative or salt thereof
EP4274577A1 (en) * 2021-01-06 2023-11-15 InCarda Therapeutics, Inc. Inhalable imatinib formulation

Family Cites Families (21)

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US4727064A (en) * 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
US5521184A (en) 1992-04-03 1996-05-28 Ciba-Geigy Corporation Pyrimidine derivatives and processes for the preparation thereof
RU2173172C2 (en) * 1997-05-05 2001-09-10 Сайдекс Инк. Solid pharmaceutical preparations containing physical mixture of cyclodextrin sulfoalkyl ether and therapeutic agent
CO4940418A1 (en) 1997-07-18 2000-07-24 Novartis Ag MODIFICATION OF A CRYSTAL OF A DERIVATIVE OF N-PHENYL-2-PIRIMIDINAMINE, PROCESSES FOR ITS MANUFACTURE AND USE
EP1027886B1 (en) * 1999-02-10 2008-07-09 Pfizer Products Inc. Pharmaceutical solid dispersions
RU2288921C2 (en) * 2000-12-19 2006-12-10 Калифорниа Инститьют оф Текнолоджи Inclusion complexes-containing compositions
US7527808B2 (en) * 2001-04-26 2009-05-05 Meiji Seika Kaisha, Ltd. Amorphous cefditoren pivoxil composition and process for producing the same
TW200305415A (en) * 2002-03-22 2003-11-01 Novartis Ag Combination of organic compounds
GB2398565A (en) * 2003-02-18 2004-08-25 Cipla Ltd Imatinib preparation and salts
US7300938B2 (en) * 2003-06-02 2007-11-27 Hetero Drugs Limited Polymorphs of imatinib mesylate
AU2005253957B2 (en) * 2004-06-08 2011-08-25 Janssen Pharmaceutica Nv Pharmaceutical compositions
US7329495B2 (en) * 2004-06-09 2008-02-12 Board Of Regents, The University Of Texas System Mutations in KIT confer imatinib resistance in gastrointestinal stromal tumors
FR2873693B1 (en) * 2004-07-29 2006-09-15 Sanofi Synthelabo AMINO-TROPANE DERIVATIVES, THEIR PREPARATION AND THEIR THERAPEUTIC APPLICATION
MX2007002398A (en) * 2004-08-27 2007-05-15 Bayer Pharmaceuticals Corp New pharmaceutical compositions for the treatment of cancer.
MY148074A (en) * 2005-05-10 2013-02-28 Novartis Ag Pharmaceutical compositions comprising imatinib and a release retardant
EP1885338A1 (en) * 2005-05-19 2008-02-13 Pfizer, Inc. Pharmaceutical compostions comprising an amorphous form of a vegf-r inhibitor
WO2006133046A2 (en) * 2005-06-03 2006-12-14 Elan Pharma International, Limited Nanoparticulate imatinib mesylate formulations
US8067421B2 (en) * 2006-04-27 2011-11-29 Sicor Inc. Polymorphic forms of imatinib mesylate and processes for preparation of novel crystalline forms as well as amorphous and form α
WO2008027600A2 (en) * 2006-09-01 2008-03-06 Teva Pharmaceutical Industries Ltd. Imatinib compositions
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Also Published As

Publication number Publication date
CL2008001658A1 (en) 2009-02-20
IL202157A0 (en) 2010-06-16
IL237160A0 (en) 2015-03-31
ZA200900796B (en) 2010-07-28
EP2305263B1 (en) 2012-09-19
CA2687741A1 (en) 2008-12-18
RU2489149C2 (en) 2013-08-10
CN101678023A (en) 2010-03-24
ZA200907961B (en) 2014-03-26
CY1113178T1 (en) 2016-04-13
MY148878A (en) 2013-06-14
PL2305263T3 (en) 2012-12-31
AU2008262059A1 (en) 2008-12-18
BRPI0812442A2 (en) 2013-02-26
JP5380440B2 (en) 2014-01-08
ES2391625T3 (en) 2012-11-28
US20100178336A1 (en) 2010-07-15
NZ598428A (en) 2013-06-28
EP2000139A1 (en) 2008-12-10
JP2013227324A (en) 2013-11-07
AR067328A1 (en) 2009-10-07
NZ581176A (en) 2012-10-26
UY31125A1 (en) 2009-01-30
AU2008262059B2 (en) 2012-04-05
US20140323495A1 (en) 2014-10-30
SG182175A1 (en) 2012-07-30
KR101267782B1 (en) 2013-06-04
CO6241118A2 (en) 2011-01-20
KR101454086B1 (en) 2014-10-27
SI2305263T1 (en) 2012-10-30
JP2010529964A (en) 2010-09-02
CN104910134A (en) 2015-09-16
WO2008154262A1 (en) 2008-12-18
NZ598427A (en) 2013-06-28
PT2305263E (en) 2012-10-22
RU2009148985A (en) 2011-08-20
EP2305263A1 (en) 2011-04-06
KR20120039717A (en) 2012-04-25
US20130225598A1 (en) 2013-08-29
US20130022672A1 (en) 2013-01-24
HK1150764A1 (en) 2012-01-13
KR20100020955A (en) 2010-02-23
MX2009013272A (en) 2010-01-25

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